Associate Manager, Regulatory Affairs Strategy – Oncology

Regeneron

Associate Manager in Regulatory Affairs focusing on Oncology at Regeneron. Coordinating regulatory submissions and supporting drug development processes for innovative therapies.

Posted 7/22/2026full-timeTarrytown • New Jersey, New York • 🇺🇸 United StatesJuniorMid-Level💰 $109,900 - $179,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance within the oncology therapeutic area, with a strong understanding of US FDA and international regulations. Capable of managing cross-functional collaboration and maintaining up-to-date knowledge of regulatory requirements.

Highest-signal resume keywords

Regulatory Submissions ManagementOncology Therapeutic Area KnowledgeUS FDA RegulationsClinical Development StrategyInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsINDs/CTAsOrphan Drug ApplicationsAnnual ReportsInvestigator’s BrochureRegulatory Strategy DevelopmentCRO InteractionDrug Development ProcessRegulatory Guidance KnowledgeProject Management

Soft Skills

Attention to DetailOrganizational SkillsCollaborationPrioritizationIndependent Judgment

Certifications & Qualifications

Bachelor's DegreeAdvanced Degree Preferred

Industry Keywords

Pharmaceutical IndustryRegulatory AffairsClinical TrialsEx-US/Ex-EU CTAsCross-Functional Team Projects

About the role

Key responsibilities & impact

Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Assisting in coordination and preparation for Agency meetings and associated briefing document preparation
Managing and tracking queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Providing representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Performing research to support the development of regulatory strategy for the assigned clinical development program
Maintaining knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercising discretion and independent judgment in the performance of the duties described above

Requirements

What you’ll need

Minimum Bachelors Degree (Advanced degree strongly preferred)
2-3 years of pharmaceutical industry experience in regulatory affairs; experience in oncology preferred
Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
High attention to detail; ability to organize and prioritize assigned projects according to corporate goals
Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
Proficient in written, oral, and interpersonal communications in English

Benefits

Comp & perks

annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits